Toileting DisabilityDUETNCT02206958
Defeating Urinary Incontinence With Exercise Training (DUET) Feasibility Study
A study testing Defeating Urinary Incontinence with Exercise Training in people with Toileting Disability and Functional Urinary Incontinence, run by University of Minnesota at 1 site in United States.
Trial summary
Pilot study to determine the feasibility and possible treatment effect of a multi-component intervention combining non-drug treatments for urinary incontinence and physical activity to improve urinary incontinence, toileting skills, physical function, and quality of life in frail older women without dementia living in… Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Toileting Disability, Functional Urinary Incontinence
- What is being tested?
- Defeating Urinary Incontinence with Exercise Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Age 60 years or older
- Have urinary incontinence
- Not currently meeting national recommendations for physical activity (150 minutes of weekly moderate intensity aerobic exercise and twice weekly strength building exercise.
- At risk for functional decline per the Vulnerable Elders Survey (score of 3+)
- Free of dementia (pass mini-cog screening)
Who cannot join
- Cognitive impairment
- Grade 4 vaginal prolapse or pessary use
- Orthopedic surgery in past year
- Urinary retention (catheter use)
- Neurological cause for urinary incontinence (i.e. Parkinson's Disease, MS)
- Bladder cancer
Show all 10Show fewer
- Bladder or incontinence surgery in past year
- Recipient of hospice or palliative care
- Ostomy
- New prescription or dosage change in past three months for anti-incontinence medication
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota School of Nursing
Minneapolis, Minnesota, 55455
About this study
Official title: Preventing Toileting Disability in Frail Older Women
Pilot study to determine the feasibility and possible treatment effect of a multi-component intervention combining non-drug treatments for urinary incontinence and physical activity to improve urinary incontinence, toileting skills, physical function, and quality of life in frail older women without dementia living in senior housing facilities.
Read the detailed description
This was a single blinded, two-arm pilot randomized controlled trial designed to test the feasibility and potential treatment effects of a multi-component intervention that combined behavioral urinary incontinence treatments with physical activity to improve urinary incontinence, toileting skills, quality of life, and physical function in frail older women without dementia living in senior apartment buildings.The intervention included a 12-week program of tailored behavioral UI treatments delivered by a nurse practitioner during 4 home visits, 150 minutes of weekly walking, and twice weekly strength training classes.
- Being tested
- Defeating Urinary Incontinence with Exercise Training
- Keywords
- Toileting disability, Functional urinary incontinence, Urinary incontinence, Frailty, Physical activity
- Medical subject headings
- Urinary Incontinence, Frailty, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Defeating Urinary Incontinence with Exercise TrainingBehavioural
12 week multi-component program. Continence program administered by a nurse practitioner during 4 home visits. Participants do pelvic floor muscle exercises 5 days/week using a 13-minute instructional audio CD. Based on participant symptoms and preferences the following strategies are taught: bladder training, urge and suppression techniques, caffeine reduction, eliminating bladder irritants, medication adjustment, adequate fluid intake, constipation management, and reducing nocturia.
- Physical activity program including moderate intensity walking (30 minutes, 5 days weekly) and twice weekly group strength training sessions using Therabands led by a trained exercise instructor.
| Study group | Role | What they receive |
|---|---|---|
| No treatment control group | Other | No treatment control group Receives: Behavioral: Defeating Urinary Incontinence with Exercise Training |
| Behavioral Urinary Incontinence Treatment | Experimental | 12 week program combining behavioral treatments for urinary incontinence and physical activity Receives: Behavioral: Defeating Urinary Incontinence with Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance Oriented Timed Toileting Instrument (POTTI)
A performance based measure that takes less than 5 minutes to administer. Participants are timed as they complete tasks that simulate toileting including: rising from a chair, walking 15 feet to another chair, turning around, pulling down an elastic waist skirt worn over their typical clothing, sitting in the chair, grabbing a piece of toileting paper and throwing it into a wastebasket, rising and pulling the skirt back up. Longer times indicate greater difficulty with toileting. It has strong inter-rater and test-retest reliability (90% agreement) and has been validated with activities of daily living dependency (r= -.721, p<.001) in nursing home residents (Ouslander et al., 1987). It has demonstrated responsiveness to change in a recent clinical trial (van Houten et. al., 2007).
Measured: baseline, after completing 12 week intervention
Toileting Skills Questionnaire
A five item toileting skills questionnaire that assesses participants level of difficulty with undressing, walking to the toilet, getting on and off the toilet, reaching to grab toilet paper, and reaching around to wipe their bottom. Responses for each item range from 0-no difficulty to 4-cannot do. Total scores range from 0-20. Higher scores indicate more difficulty.
Measured: baseline, after completing 12 week intervention
Secondary outcomes (6)
International Consultation on Incontinence Questionnaire (ICIQ)
A four item questionnaire reporting the frequency and amount of urine leakage, how much leakage interferes with everyday life, and when leaking occurs. Scores range from 0-21 with higher scores indicating greater severity.
Measured: baseline, after completing 12 week intervention
3 day bladder diary
Measured: baseline, after completing 12 week intevention
Short Physical Performance Battery
Performance based test of balance, gait, and chair rising ability.
Measured: baseline, after completing 12 week intervention
Environmental toileting barriers checklist
Observation of environmental barriers to toilet access, i.e., inappropriate toilet seat height, grab bar placement, trip hazards on pathway to toilet, adequate lighting in bathroom and pathways to toilet and other barriers to easy toileting.
Measured: baseline
Incontinence Impact Questionnaire (IIQ)
The IIQ is a questionnaire with 30 items measuring the impact urinary incontinence has on social, physical, emotional, and psychological aspects of life. All items contain the same response options (0=not at all, 1=slightly, 2= moderately, 3=greatly) and scores range from 0-90.
Measured: baseline, after completing 12 week intervention
Urogenital Distress Inventory (UDI)
The UDI has 20 items asking about how much urinary incontinence bothers the respondent. All items contain the same response options (0=not at all, 1=slightly, 2= moderately, 3=greatly) and scores range from 0-60.
Measured: baseline, after completing 12 week intevention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study startMar 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Toileting DisabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02206958
- Sponsor's protocol ID
- 1112S07944
- Acronym
- DUET
- Status last verified
- May 2019
- First submitted
- 30 Jul 2014
- Last updated
- 6 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Talley KMC, Wyman JF, Bronas U, Olson-Kellogg BJ, McCarthy TC. Defeating Urinary Incontinence with Exercise Training: Results of a Pilot Study in Frail Older Women. J Am Geriatr Soc. 2017 Jun;65(6):1321-1327. doi: 10.1111/jgs.14798. Epub 2017 Mar 1.
PubMed 28248418
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Toileting Disability in Frail Older Women
- ClinicalTrials.gov ID
- NCT02206958
- Acronym / sponsor ID
- DUET / 1112S07944
- Keywords
- Toileting disability, Functional urinary incontinence, Urinary incontinence, Frailty, Physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 1 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pilot study to determine the feasibility and possible treatment effect of a multi-component intervention combining non-drug treatments for urinary incontinence and physical activity to improve urinary incontinence, toileting skills, physical function, and quality of life in frail older women without dementia living in senior housing facilities.
Detailed description
This was a single blinded, two-arm pilot randomized controlled trial designed to test the feasibility and potential treatment effects of a multi-component intervention that combined behavioral urinary incontinence treatments with physical activity to improve urinary incontinence, toileting skills, quality of life, and physical function in frail older women without dementia living in senior apartment buildings.The intervention included a 12-week program of tailored behavioral UI treatments delivered by a nurse practitioner during 4 home visits, 150 minutes of weekly walking, and twice weekly strength training classes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No treatment control group | Other | Behavioral: Defeating Urinary Incontinence with Exercise TrainingNo treatment control group |
| Behavioral Urinary Incontinence Treatment | Experimental | Behavioral: Defeating Urinary Incontinence with Exercise Training12 week program combining behavioral treatments for urinary incontinence and physical activity |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female
- Age 60 years or older
- Have urinary incontinence
- Not currently meeting national recommendations for physical activity (150 minutes of weekly moderate intensity aerobic exercise and twice weekly strength building exercise.
- At risk for functional decline per the Vulnerable Elders Survey (score of 3+)
Key exclusion criteria (10 listed)
- Cognitive impairment
- Grade 4 vaginal prolapse or pessary use
- Orthopedic surgery in past year
- Urinary retention (catheter use)
- Neurological cause for urinary incontinence (i.e. Parkinson's Disease, MS)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Defeating Urinary Incontinence with Exercise Training12 week multi-component program. Continence program administered by a nurse practitioner during 4 home visits. Participants do pelvic floor muscle exercises 5 days/week using a 13-minute instructional audio CD. Based on participant symptoms and preferences the following strategies are taught: bladder training, urge and suppression techniques, caffeine reduction, eliminating bladder irritants, medication adjustment, adequate fluid intake, constipation management, and reducing nocturia. 2. Physical activity program including moderate intensity walking (30 minutes, 5 days weekly) and twice weekly group strength training sessions using Therabands led by a trained exercise instructor. | Behavioural | Behavioral Urinary Incontinence Treatment, No treatment control group |
Primary outcome
Performance Oriented Timed Toileting Instrument (POTTI)
Time frame: baseline, after completing 12 week intervention
A performance based measure that takes less than 5 minutes to administer. Participants are timed as they complete tasks that simulate toileting including: rising from a chair, walking 15 feet to another chair, turning around, pulling down an elastic waist skirt worn over their typical clothing, sitting in the chair, grabbing a piece of toileting paper and throwing it into a wastebasket, rising and pulling the skirt back up. Longer times indicate greater difficulty with toileting. It has strong inter-rater and test-retest reliability (90% agreement) and has been validated with activities of daily living dependency (r= -.721, p<.001) in nursing home residents (Ouslander et al., 1987). It has demonstrated responsiveness to change in a recent clinical trial (van Houten et. al., 2007).
Toileting Skills Questionnaire
Time frame: baseline, after completing 12 week intervention
A five item toileting skills questionnaire that assesses participants level of difficulty with undressing, walking to the toilet, getting on and off the toilet, reaching to grab toilet paper, and reaching around to wipe their bottom. Responses for each item range from 0-no difficulty to 4-cannot do. Total scores range from 0-20. Higher scores indicate more difficulty.
6 secondary outcomes
International Consultation on Incontinence Questionnaire (ICIQ)
Time frame: baseline, after completing 12 week intervention
3 day bladder diary
Time frame: baseline, after completing 12 week intevention
Short Physical Performance Battery
Time frame: baseline, after completing 12 week intervention
Environmental toileting barriers checklist
Time frame: baseline
Incontinence Impact Questionnaire (IIQ)
Time frame: baseline, after completing 12 week intervention
Urogenital Distress Inventory (UDI)
Time frame: baseline, after completing 12 week intevention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
- Background: PubMed 28248418Talley KMC, Wyman JF, Bronas U, Olson-Kellogg BJ, McCarthy TC. Defeating Urinary Incontinence with Exercise Training: Results of a Pilot Study in Frail Older Women. J Am Geriatr Soc. 2017 Jun;65(6):1321-1327. doi: 10.1111/jgs.14798. Epub 2017 Mar 1.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Defeating Urinary Incontinence with Exercise Training in people with Toileting Disability and Functional Urinary Incontinence, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance Oriented Timed Toileting Instrument (POTTI) (time frame: baseline, after completing 12 week intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02206958, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2019; AzTrials last refreshed its copy on 29 Oct 2026.